Quantrx Female Fertility Test
FDA 510(k) K070484 · Quantrx Biomedical Corporation
510(k) numberK070484
Submission
- Device name
- Quantrx Female Fertility Test
- Applicant
- Quantrx Biomedical Corporation
San Diego, CA, US - Received
- February 20, 2007
- Decision date
- October 22, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NGA – Test, Follicle Stimulating Hormone (Fsh), Over The Counter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1300
- Specialty
- Clinical Chemistry
Other 510(k)s with product code NGA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032002 | Fertell Female Fertility TestNGA · Traditional | Genosis, Inc. | 10/30/2003SE |
More from Genosis, Inc.
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| K080436 | Rapidsense Drugs of Abuse Cocaine (Coc) 300 Device, Model 900-0052DIO · Traditional | 02/11/2009SE |
| K080431 | Rapidsense Drugs of Abuse Phencyclidine (PCP) 25 Device with Models 900-0054LCM · Traditional | 01/08/2009SE |
| K080455 | Rapidsense Drugs of Abuse Methamphetamine (Met) 1000 Device, Model 900-0050LAF · Traditional | 12/31/2008SE |
Questions and answers
When was Quantrx Female Fertility Test cleared by the FDA?
Quantrx Female Fertility Test (K070484) received a 510(k) decision of Substantially Equivalent on October 22, 2007, 244 days after the submission was received.
What is the product code of K070484?
The FDA product code is NGA – Test, Follicle Stimulating Hormone (Fsh), Over The Counter, a Class I (low risk) device regulated under 21 CFR 862.1300.